Z-2279-2012Class II

V Series Patient Monitors; Mindray DS USA, Inc

Name: Z-2279-2012 V Series Patient Monitors; Mindray DS USA, Inc
Creator: Mindray DS USA, Inc. d.b.a. Mindray North America
Published: 2012-05-07
License: https://open.fda.gov/license/

Datascope Corp. / initiated 2012-05-07 / Terminated / root cause: software

FDA source

Mindray DS USA, Inc. d.b.a. Mindray North America began a recall of V Series Patient Monitors; Mindray DS USA, Inc. Product Usage: The V Series Monitor is intended for intra hospital use under the direct supervision of a... on 2012-05-07. FDA classified it as Class II and gives the reason as "Mindray has identified two software anomalies contained in the V Series Monitoring System. There have been no reports of injuries associated with these anomalies. These anomalies affect V Series Systems distributed...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-2279-2012
Classification: Class II
Status: Terminated
Initiated: 2012-05-07
Posted: 2012-08-28
Terminated: 2013-07-17
Recalling firm: Datascope Corp.
Product: V Series Patient Monitors; Mindray DS USA, Inc. Product Usage: The V Series Monitor is intended for intra hospital use under the direct supervision of a licensed healthcare practitioner. The indications for Use for the V Series include the monitoring of the following human physiological parameters: ECG waveform derived from 3, 5, 6 and 12 lead measurements; Heart Rate; Pulse Oximetry (SpO2); ST Segment Analysis; Arrhythmia Detection; Non Invasive Blood Pressure (NIBP); Invasive Blood Pressure (IBP); Cardiac Output (CO); Respiratory Gasses; Respiration Rate; and Temperature. The V Series Monitor has the capability of performing IV Drug and Hemodynamic Calculations and interfacing with network devices. The target populations are adult, pediatric and neonate with the exception of: Arrhythmia detection and ST Segment Analysis, for which the target populations are adult and pediatric only; IV Drug Calculations for which the target population is adult only; and Cardiac Output for which the target population is adult and pediatric only.
Product code: MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Reason for recall: Mindray has identified two software anomalies contained in the V Series Monitoring System. There have been no reports of injuries associated with these anomalies. These anomalies affect V Series Systems distributed between September 31, 2010 and January 9, 2012.
Root cause tag: software
FDA root cause: Software design
Action: Mindray sent an Urgent: V Series Monitoring System Correction letters dated May 7, 2012 via certified mail to all affect customer. The letter identified the affected product, problem and actions to be taken. Customers are directed that VPS modules should not be used between systems until a software upgrade has been completed. This work will be done at no cost to the customer. For questions contact your Mindray Serviice Representative at 1-800-288-2121.
Quantity in commerce: 979 units
Distribution: Worldwide Distribution - US Nationwide including the states of: NY, SD, NE, IL, MO, CA, OH, OK, WA, IN, WY, CO, TX, FL, NC, AL and Puerto Rico. and the countries of: Australia, Canada, Columbia, New Zealand, Pakistan, Russia, Saudi Arabia, United Kingdom and Venezuela.
Product codes and lots: V Series Monitor Part Numbers 0998-00-1800-101 and 0998-00-1800-201.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2279-2012
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2279-2012	Class II	Terminated	Voluntary: Firm initiated	2012-09-05	2012-08-27

Product code MHX

K102004Class IIEndeavour Monitoring SystemMindray DS USA, Inc. / cleared 2010-09-10

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)